ABT 450/r, ABT 267, ABT 333 combo submitted to EU for Hepatitis C-AbbVie
AbbVie submitted marketing authorization applications (MAAs) to the European Medicines Agency (EMA) seeking approval for the all-oral, interferon-free regimen ABT 450/ritonavir and ABT 267 (ombitasvir) and ABT 333 (dasabuvir) for the treatment of adult patients with chronic genotype 1 (GT1) Hepatitis C Virus (HCV) infection. The application is supported by data from the largest all-oral, interferon-free clinical program in GT1 patients conducted to date, which consists of six Phase III studies that include more than 2,300 patients in over 25 countries.
Review of AbbVie's MAAs will be conducted under the centralized licensing procedure which, when finalized, provides one marketing authorization in all 28 member states of the European Union (EU). If approved, ABT-450/ritonavir, ombitasvir (ABT-267), and dasabuvir (ABT-333) could be available for marketing in the EU in the first quarter of 2015. This combination is filed with the FDA for the same indication.
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